Proregulations, a leading provider of product consulting and regulatory compliance solutions, launches a strategic approach for achieving ASMF compliance. The strategic approach helps API manufacturers solve many problems and provide convenience in applying for and evaluating ASMF.

The EU Active Substance Master File (ASMF) is a technical document containing confidential information on an API that is submitted by the manufacturer of the API to the EMA or the medicines regulatory authority of an EU member state. As a form of DMF in the EU, the ASMF is used to support MAA or MAV by manufacturers of pharmaceutical preparations for human or veterinary use.

The ASMF applies to applications for new active substances, pharmacopeial active substances (included in the EP), and existing active substances (excluded from the EP). The ASMF allows the associated marketing authorization holder of the formulation to have access to the necessary information for quality control of the API, while protecting the API manufacturer’s core technical secrets.

At Proregulations, its team of professionals has an in-depth understanding of the EU’s ASMF regime and extensive experience in producing ASMFs that meet regulatory requirements. Proregulations provides personalized ASMF compliance services that cover not only the preparation and submission of technical documents, but also effective communication with regulators.

Proregulations offers Active Substance Master File (ASMF) compliance services tailored to pharmaceutical manufacturers seeking European market access. The company’s multifaceted approach encompasses five critical service areas to ensure regulatory success. Their Regulatory Interpretation and Consulting service delivers expert guidance on ASMF application scope, review processes, and documentation requirements. Through meticulous Compliance Assessment, Proregulations analyzes ASMF feasibility according to current EU regulations and conducts thorough gap analyses to identify potential compliance issues. The firm excels in ASMF Writing. The overall content of the ASMF should contain detailed scientific information, and the ASMF filing is divided into an Applicant Part (AP) and a Restriction Part (RP). Proregulations assists clients in the preparation of the complete ASMF and ensures that all documents comply with EU specifications and requirements. Their ASMF Submission service includes professional pre-review with recommended revisions before formal submission through the Common European Submission Portal (CESP). Furthermore, Proregulations provides ongoing ASMF Lifecycle Management to maintain documentation currency through their revision and update services. This integrated suite of compliance solutions enables pharmaceutical companies to navigate complex European regulatory requirements efficiently while maintaining the highest standards of regulatory compliance throughout the product lifecycle.

About Proregulations

Proregulations is committed to providing efficient and customized solutions to various industries around the globe, including regulatory interpretation, policy consultation, document preparation, and submission. The team has insight into the differences in regulatory processes in different countries/regions, and services cover the full life cycle of products. Proregulations’ service areas range from chemicals, pharmaceuticals, medical devices, cosmetics, food & dietary supplements to agrochemicals & biocides. The featured services include, but are not limited to, FDA Medical Device Registration, 510(k) Premarket Notification, Drug Master File Document, FDA ANDA, FDA NDA, IND Application, New Dietary Ingredients Compliance, FDA Agent Services, Medical Device Distributor License, TSCA Compliance, China Cosmetics Registration, etc.